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Month: August 2020

RedHill Biopharma 宣佈由獨立委員會提出積極建議,繼續進行美國第 2 期 COVID-19 研究,並在意大利獲批進行 COVID-19 第 2/3 期研究

預先排定的獨立安全監控委員會(SMC)已提出建議,使用 opaganib 進行的美國第 2 期 COVID-19 研究繼續進行並保持不變;目前研究的納入率超過 50%,並且計劃在未來幾週內完成納入—使用 opaganib 的全球第 2/3 期 COVID-19 研究與美國第 2 期研究平行進行,並在意大利順利獲批;而該研究也已在英國、俄羅斯和墨西哥獲得批准,且正在其他國家/地區進行審查—使用 opaganib 進行的全球第 2/3 期研究計劃已納入首批患者,計劃在 40 個臨床中心納入最多 270 名嚴重 COVID-19 肺炎住院患者—計劃最早在 2020 年第四季提交全球緊急用途申請

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Vibe Announces Agreement to Acquire California Distribution and Manufacturing Business

SACRAMENTO, Calif., Aug. 30, 2020 (GLOBE NEWSWIRE) — Vibe Bioscience Ltd. (CSE:VIBE, OTC:VBSCF, GERMANY:A061) (the “Company” or “Vibe”), a California based cannabis retailer and cultivator, is pleased to announce it has entered into a definitive agreement to acquire Cathedral Asset Holding Corporation (“CAHC” or “Cathedral”) and its distribution and manufacturing assets in Santa Rosa, California. CAHC is a wholly owned subsidiary of Ventura Cannabis and Wellness Corp. (CSE: VCAN) (“Ventura”)“The acquisition of Cathedral makes Vibe a true, vertically integrated cannabis cultivator, distributor, manufacturer and retailer in California, focused on the most dynamic cannabis market in the United States. Vibe is singularly focused on developing cannabis assets that are cash flow positive, and we anticipate the acquisition will be highly...

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Saudi Stock Exchange (Tadawul) Launches New Derivatives Market and Clearinghouse Leveraging Nasdaq Market Technology

RIYADH, Saudi Arabia and STOCKHOLM, Sweden, Aug. 30, 2020 (GLOBE NEWSWIRE) — The Saudi Stock Exchange (Tadawul) announced today it has officially launched its first Derivatives Market and a clearinghouse, The Securities Clearing Centre Company (Muqassa), both of which are running on Nasdaq’s (Nasdaq: NDAQ) market technology. The first exchange-traded derivatives product is MT30 Index Futures, an index futures contract based on the MSCI Tadawul 30 Index (MT30), which will benefit from central counterparty clearing by Muqassa.This new market offering provides regional and international investors the necessary hedging tools to manage risk, and to expand exposure opportunities to one of the largest and most liquid markets in the world, the Saudi market. As the market infrastructure develops, Tadawul plans to roll out more derivatives...

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Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

Pooled data from Phase III ORION-10 and -11 showed highly consistent efficacy, tolerability and safety profile over 17 months on twice-yearly subcutaneous dosing in 2,300 patients (of which 1,164 were on inclisiran) 1 New post-hoc analysis demonstrates 99% of patients treated with inclisiran showed placebo-adjusted reduction in low-density lipoprotein cholesterol (LDL-C) of ≥30% with a mean reduction of 54.1% from baseline (observed values)2 88% of inclisiran-treated patients achieved LDL-C placebo-adjusted reduction of at least 50% at any time point during the study (observed values)2 Inclisiran is currently under review by the FDA and the EMA for the treatment of primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapyBasel,...

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Genetron Health Joins Major R&D Project Led by the Ministry of Science and Technology in China for Early Screening of Lung and Digestive System Cancers

BEIJING, Aug. 29, 2020 (GLOBE NEWSWIRE) — Genetron Holdings Limited (“Genetron Health” or the “Company”, Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, today announced its participation in the launch of a major national research project for early screening of lung and digestive system cancers led by China’s Ministry of Science and Technology (“MOST”).Based on the Company’s proprietary technology, Mutation CapsuleTM, Genetron Health is collaborating with the National Cancer Center and the Cancer Hospital, Chinese Academy of Medical Sciences (“CAMS”) for the second time, to provide key technological contributions for the “Liquid Biopsy-based Malignant Tumor Early Screening Technology Research and Development Project”. The launch meeting for the project...

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MyoKardia Presents Results from Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy

EXPLORER-HCM Data Presented During Live Hot Line Session at ESC Congress 2020 with Simultaneous Publication in The LancetPresentation Expands on Positive Topline Results Showing Early, Sustained Reductions in Biomarkers of Cardiac Wall Stress and Myocardial InjuryMavacamten Demonstrated Broad Treatment Effect, with Consistent Benefit Across Primary and Secondary Endpoints Among All Prespecified Patient SubgroupsMyoKardia to Host a Virtual Analyst and Investor Event toReview Data on Monday, August 31 at 8:00 a.m. EDTBRISBANE, Calif., Aug. 29, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) announced today that 30-week results from its pivotal Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM) were presented during a live Hot Line session at the...

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Medtronic Cryoablation Superior to Drug Therapy for Symptomatic Paroxysmal Atrial Fibrillation

ESC Congress: New Research Highlights First-Line Use of Cryoablation as Highly Effective, and with Improved Quality of Life ScoresDUBLIN, Aug. 29, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced clinical trial results demonstrating superiority of the Arctic Front™ Advance Cardiac Cryoballoon and Freezor® MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) compared to antiarrhythmic drug (AAD) treatment. Primary results of the randomized STOP AF First trial were presented as a late breaking clinical trial at the European Society of Cardiology (ESC) Congress 2020 Digital Experience. Additionally, 12-month outcomes from the Cryo-FIRST trial showed a significant improvement in atrial...

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LexinFintech Wins The Asian Banker Award for Best AI and Innovation Lab in China

SHENZHEN, China, Aug. 29, 2020 (GLOBE NEWSWIRE) — LexinFintech Holdings Ltd. (“Lexin”) (NASDAQ: LX), a leading online consumption and consumer finance platform for educated young professionals in China, has been awarded the Best AI and Innovation Lab Award in China by The Asian Banker, whose awards are seen as an undisputed benchmark measuring the performance of the best banks and fintech companies in Asia.“Lexin’s AI Lab significantly enhanced the company’s operating efficiency and increased its profitability by providing automated artificial intelligence services throughout every step of its transaction processes. Both of its research and development (R&D) expense and R&D personnel as a percentage of total employee headcount have been maintained at levels that lead the industry,” The Asian Banker commented.A...

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NGM Bio Presents Comprehensive Findings from 24-Week Phase 2 Study (Cohort 4) of Aldafermin in Oral Plenary Presentation at The Digital International Liver Congress™ (ILC) 2020 and Announces Enrollment Completed in Phase 2b ALPINE 2/3 Study

Late-breaker presentation selected as “Best of ILC”The 24-week Phase 2 study met its primary endpoint, achieving a statistically significant reduction in liver fat content (LFC), and robust fibrosis improvement and resolution of NASH, with a favorable safety profileNew analysis shows 30% placebo corrected anti-fibrotic response rate among NASH patients with more advanced liver fibrosis (F3)NGM Bio anticipates Phase 2b ALPINE 2/3 study topline data readout in Q2 2021SOUTH SAN FRANCISCO, Calif., Aug. 29, 2020 (GLOBE NEWSWIRE) — NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that final data from its 24-week Phase 2 study (Cohort 4) of aldafermin 1 mg in patients with non-alcoholic steatohepatitis (NASH) were featured...

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